Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.

Key facts

Study ID

NCT02522780

Run by

Ferring Pharmaceuticals

People needed

276

Starts

2016-02-01

Expected to finish

2018-09-19

Last updated by the study team

2021-11-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged 18 to 75 years, with Ulcerative Colitis in remission

You may not qualify if…

• Evidence of other forms of inflammatory bowel disease
• Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV])
• Disease limited to proctitis <15 cm
• Short bowel syndrome
• Prior colon resection surgery
• History of severe/fulminant UC
• Intolerant or allergic to aspirin or salicylate derivatives
• Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days
• Women who are pregnant or nursing
• History of known malignancy
• History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/ emotional disorders, that would interfere with their participation in the trial

Where it is running

• United Research Institute — Murrieta, California, United States
• Research Associates of South Florida, LLC — Miami, Florida, United States
• IMIC — Palmetto Bay, Florida, United States
• Medical Research Center of Florida — Pembroke Pines, Florida, United States
• Lenus Research and Medical Group — Sweetwater, Florida, United States
• Clinical Trials of SWLA, LLC — Lake Charles, Louisiana, United States
• Cumberland Research Associates, LLC — Fayetteville, North Carolina, United States
• Wilmington Gastroenterology Associates — Wilmington, North Carolina, United States
• Associates in Gastroenterology, PLC — Hermitage, Tennessee, United States
• Quality Medical Research, PLLC — Nashville, Tennessee, United States
• BI Research Center — Houston, Texas, United States
• Biopharma Informatic Inc. — Houston, Texas, United States
• Digestive Health Center — Pasadena, Texas, United States
• DM Clinical Research — Tomball, Texas, United States
• Advanced Research Institute — Ogden, Utah, United States
• New River Valley Research Institute — Christiansburg, Virginia, United States
• Digestive & Liver Disease Specialists — Norfolk, Virginia, United States
• Multiprofile Hospital For Active Treatment Avis Medica — Pleven, Bulgaria
• University Multiprofile Hospital for Active Treatment Kaspela — Plovdiv, Bulgaria
• Medical Center Excelsior OOD — Sevlievo, Bulgaria
• Medical Center-1-Sevlievo EOOD — Sevlievo, Bulgaria
• City Clinic University Multiprofile Hospital for Active Treatment EOOD — Sofia, Bulgaria
• Medical Center Asklepion - Humane Medicine Research EOOD — Sofia, Bulgaria
• University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD — Sofia, Bulgaria
• Preferred Research Partners — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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